EUCTR2020-004836-93-DE进行中（未招募）1 期
An Exploratory Study to Assess the 24-hour Intraocular Pressure (IOP) Lowering Characteristics, Duration of Action and Safety of DE-126 ophthalmic solution 0.002% versus Latanoprost ophthalmic solution 0.005% in Subjects with Primary Open Angle Glaucoma or Ocular Hypertension
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Provide signed written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF).
- •2. Be 18 years of age or older on the date of signing the ICF and be able and willing to comply with all treatment and follow-up study procedures.
- •3. If a subject is a female of childbearing potential (i.e., not post-menopausal [within 12 months since the last menses] or not surgically sterile [less than 6 months from date of surgery]), she must have a negative urine pregnancy test and must use at least one of the following acceptable contraceptive methods used consistently and correctly during the study (as well as for 4 weeks following the last dose in the study).
- •combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- •b. intravaginal
- •c. transdermal
- •progestogen-only hormonal contraception associated with inhibition of ovulation:
- •b. injectable
- •c. implantable
- •intrauterine device (IUD)
- •intrauterine hormone-releasing system (IUS)
- •bilateral tubal occlusion
- •vasectomised partner
- •sexual abstinence
- •4. The male partner of the female subject of childbearing potential should use or practice an acceptable contraceptive method, such as abstinence, condom or vasectomy (surgery atleast 6 months prior to signing the study ICF and beginning screening), or other
- •contraception deemed adequate by the investigator during the study.
- •a . Male subjects, with a female partner of childbearing potential, should use or practice an acceptable contraceptive method, such as abstinence, condom or vasectomy (surgery at least 6 months prior to signing the study ICF), or other contraception deemed adequate by the investigator during the study.
- •5. Must have a diagnosis of Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) in both eyes or one eye with POAG and the other with OHT.
- •6. BCVA of +0.60 logMAR (Snellen equivalent 20/80) or better in each eye.
- •7. Central corneal thickness = 480 ?m and = 600 ?m in each eye.
- •8. Anterior chamber angle grade = 2 (Shaffer scale) in each eye.
- •In addition to continuing to meet inclusion criterion 6 (BCVA), the subject must meet the following criteria at Visit 2 (Eligibility, D -2):
- •9. Completed the required wait/washout period (if required per protocol).
- •10. At all time points of IOP measurements (08:00, 12:00, and 16:00) at Visit 2 (Eligibility, D -2), have IOP of = 22 mmHg in at least one eye (the same eye), and = 34 mmHg in both eyes.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •At Visit 1 (Screening) and Visit 2 (Eligibility, D -2), subjects with any of the following ocular conditions in either eye or with any of the following non-ocular conditions or characteristics are not eligible to participate in the study:
- •1. Females who are pregnant, nursing, or planning a pregnancy.
- •2. Subjects with known or suspected drug or alcohol abuse.
- •3. Participation in other investigational drugs (oral or topical therapy) or device clinical trials within 28 days prior to Visit 2 (Eligibility, D -2) and/or participation in other investigational drugs (intravitreal injection therapy) within 3 months or 5 half-lives (whichever is longer) prior to Eligibility, Day -2, or planning to participate in other investigational drug or device clinical trials during a time which would overlap with the duration of the study. This includes both ocular and non-ocular clinical trials. Exposure to investigational biologics should be discussed with the medical monitor.
- •Medications / Therapies
- •4. Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period.
- •5. Subjects who will be required to initiate or modify any systemic or topical medication known to affect IOP (e.g., ß-adrenergic antagonists, a-adrenergic agonists, calcium channel blockers, angiotensin-converting enzyme [ACE] inhibitors, and angiotensin II receptor blockers [ARBs]). Subjects using the above medications must be on a stable dose use for at least 28 days prior to Visit 2 (Eligibility, D -2) and the duration of the study.
- •6. Intended or current use of the following prohibited medications/therapies during the
- •study duration:
- •All ocular medications other than sodium chloride/potassium chloride ophthalmic solution, cataract treatment agents (e.g., lutathione, pirenoxine), Vitamin B12 formulation (e.g., cyanocobalamine), over-the-counter artificial tears/drops, and
- •study medications.
- •All systemically administered ocular hypotensive medications (e.g., oral or intravenous CAI, oral glycerol).
- •Any ocular, periocular, inhaled, nasal, or systemic corticosteroids (excluding joint injections).
- •? Lacrimal/punctal occlusion via plug(s) or cautery.
- •7. Known allergy, hypersensitivity, or contraindications to prostaglandins, or any other
- •components (e.g., Benzalkonium Chloride [BAK]) of the study medications or other
- •study-related procedures/medications.
- •8. History of ocular surgery specifically intended to lower IOP (e.g., laser trabeculoplasty, filtering surgery, tube shunt, Minimally Invasive Glaucoma Surgery (MIGS), or trabeculotomy) in either eye. Please note that a history of laser iridotomy is allowed.
- •9. History of keratorefractive surgery (e.g., radial keratotomy [RK], photorefractivekeratectomy [PRK], laser-assisted-in-situ keratomileusis [LASIK]) in either eye.
- •10. Use of contact lenses within 1-2 weeks prior to Visit 2 (Eligibility, D -2) until end of treatment in either eye (1 week for soft contact lens wearers, and/or 2 weeks for rigid contact lens wearers).
- •11. Any ocular surgery within 180 days prior to Visit 2 (Eligibility, D -2) and throughout the
- •study in either eye.
- •12. Presence of advanced glaucoma (e.g., visual field mean deviation worse than -12 dB) in either eye.
- •13. Presence of any corneal abnormality or other conditions interfering with or preventing reliable Goldmann applanation tonometry (e.g., Fuch’s dystrophy or significant corneal surface abnormality) in either eye.
研究者
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